Topical paromomycin with or without gentamicin for cutaneous leishmaniasis
| Autor: | Diane Ullman, Aicha Boukthir, Nabil Belhadj Hamida, Ryan C. Adams, Kirsten S. Smith, Mourad Mokni, Jihene Bettaieb, Zaher El Ahmadi, Philip L. Smith, Adel Gharbi, Robert M. Rice, George D. Thorne, Nissaf Ben Alaya, A. Zaatour, Carl J. Nielsen, Jeanne A. Norwood, Max Grogl, Hechmi Louzir, Sadok Chlif, Gloria Morizot, William F. McCarthy, Alan J. Magill, Afif Ben Salah, Mara Kreishman-Deitrick, Karen M. Kopydlowski, Janet Ransom, Judith Berman, Pierre Buffet, Nathalie Ben Messaoud, Kidar Abdelhamid, Evelyn Guedri, Douglas B. Tang |
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| Přispěvatelé: | Institut Pasteur de Tunis, Réseau International des Instituts Pasteur (RIIP), Regional Hospital of Gafsa, Regional Directorate of Health, Department of Dermatology, Hôpital La Rabta [Tunis], Institut Pasteur [Paris], Immunité et Infection, Université Pierre et Marie Curie - Paris 6 (UPMC)-IFR113-Institut National de la Santé et de la Recherche Médicale (INSERM), U.S. Army Medical Materiel Development Activity, Fort Detrick, Fast-Track Drugs and Biologics, North Potomac, Division of Experimental Therapeutics, Walter Reed Army Institute of Research, Supported by the Department of the Army. The investigators have adhered to the policies for protection of human subjects asprescribed in Army Regulation 70-25., Institut Pasteur [Paris] (IP) |
| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Male
MESH: Paromomycin Paromomycin Administration Topical MESH: Intention to Treat Analysis Ointments 0302 clinical medicine [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases MESH: Child MESH: Ointments Medicine Leishmania major Child MESH: Aged 0303 health sciences MESH: Middle Aged Index Lesion biology General Medicine Middle Aged Intention to Treat Analysis 3. Good health MESH: Administration Topical MESH: Young Adult Child Preschool Drug Therapy Combination Female Gentamicin medicine.symptom medicine.drug Adult medicine.medical_specialty MESH: Gentamicins Adolescent 030231 tropical medicine Leishmaniasis Cutaneous Lesion Young Adult 03 medical and health sciences Cutaneous leishmaniasis parasitic diseases Humans Aged 030304 developmental biology MESH: Adolescent Intention-to-treat analysis MESH: Humans business.industry MESH: Child Preschool Leishmaniasis MESH: Adult medicine.disease biology.organism_classification MESH: Leishmaniasis Cutaneous Dermatology MESH: Male carbohydrates (lipids) MESH: Drug Therapy Combination Gentamicins business MESH: Female |
| Zdroj: | New England Journal of Medicine New England Journal of Medicine, Massachusetts Medical Society, 2013, 368 (6), pp.524-32. ⟨10.1056/NEJMoa1202657⟩ New England Journal of Medicine, 2013, 368 (6), pp.524-32. ⟨10.1056/NEJMoa1202657⟩ |
| ISSN: | 0028-4793 1533-4406 |
| DOI: | 10.1056/NEJMoa1202657⟩ |
| Popis: | International audience; BACKGROUND: There is a need for a simple and efficacious treatment for cutaneous leishmaniasis with an acceptable side-effect profile. METHODS: We conducted a randomized, vehicle-controlled phase 3 trial of topical treatments containing 15% paromomycin, with and without 0.5% gentamicin, for cutaneous leishmaniasis caused by Leishmania major in Tunisia. We randomly assigned 375 patients with one to five ulcerative lesions from cutaneous leishmaniasis to receive a cream containing 15% paromomycin-0.5% gentamicin (called WR 279,396), 15% paromomycin alone, or vehicle control (with the same base as the other two creams but containing neither paromomycin nor gentamicin). Each lesion was treated once daily for 20 days. The primary end point was the cure of the index lesion. Cure was defined as at least 50% reduction in the size of the index lesion by 42 days, complete reepithelialization by 98 days, and absence of relapse by the end of the trial (168 days). Any withdrawal from the trial was considered a treatment failure. RESULTS: The rate of cure of the index lesion was 81% (95% confidence interval [CI], 73 to 87) for paromomycin-gentamicin, 82% (95% CI, 74 to 87) for paromomycin alone, and 58% (95% CI, 50 to 67) for vehicle control (P |
| Databáze: | OpenAIRE |
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